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HUMAN ETHICS COMMITTEE

May 27,2011

To,Dr. K. Dholam,Principal Investigator,

TMH.

Ref: Final Approval -Project No. 856

Dear Dr. Dholam,

Human Ethics Committee-I reviewed and discussed your application dated 18.01.2011 to conduct theresearch study entitled "Oral Health Of Children With Leukemia And Its Co-Relation To Outcome -Pilot Study" during the HEC-I meeting held on 26.05.2011 at 8.30 a.m. in the Institutional Review BoardMeeting Room, Main Bldg., 3rd Floor, Tata Memorial Hospital.

The following documents were reviewed:

1. Project Submission fonn

2. MC-Scientific Review Committee approval dated 15.02.2011

Study Protocol

CV of Principal Investigator and oo-investiga ors

d on 03.05.2011 the above mentioned documents weree committee had suggested changes and HEC query Letter

e se I er ated 12.05.2011 along with the below mentioned documents withe SU~I9el:;tedchanges wlhich were revie ed and approved on 27.05.2011.

1. Parent Infonned Consent Fonn version 2.0 dated May 2011 in English, Hindi and Marathi

2. Child Assent Form version 2.0 dated May 2011 in English, Hindi and Marathi

3. Study Protocol

The following members of the Human Ethics comrnittee-l (HEC-I) were present at the meeting held on03.05.2011 at 8.30 a.m. in the Institutional Review Board Meeting Room, Main Bldg., 3rd Floor, TataMemorial Hospital

Final approval Project No. 856Page 1 of 3

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Sr. Names Affiliation Gender ExpertiseNo.

1. Dr. Tapan Saikia Medical Oncologist, Prince Aly Khan Male Medical OncologistActing Chairperson Hospital

2. Dr. J. V. Divatia Professor, Dept. of Anaesthesia, Male AnaesthetistMember Secretary Tata Memorial Centre

IRS OfficeDr. E. Borges Marg, Parel,Mumbai - 400 012. IndiaPhone: 022-2417 7262Fax:022-22 2414 6937

E-mail: tmhethics@gmail.comWebsite: http://tmc.gov.in

Cancer is curable, if detected early

-3. Dr. N. Gogtay, Associate Professor, Clinical Female Clinical Pharmacologist

Member Pharmacology, KEM Hospital4. Dr. Pradnya Talawadekar, Project Manager of Ojus Medical Female Legal expert

Member Institute, Juhu.5. Ms. Mrunal Marathe, Medical Counselor Female Social scientist

Member6. Dr. Tanuja Shet, Professor & Pathologist, Dept. of Female Pathologist

Member Pathology, TMH7. Ms. Viji Venkatesh, Head, Max Station India & Asia Female Lay person

Member Pacific Region Co ordinator8. Dr. A. Lobo Gajiwala, Head, Dept. of Tissue Bank, Female Social Scientist

Member Tata Memorial Hospital

The study is approved in its presented form. The approval is valid until one year from the date ofsanction. You may make a written request for renewal! extension of the validity, along with thesubmission of annual status report. The study should be initiated only after registration of the studywith Clinical Trials Registry India (CTRI).

Following points must be noted:

1. HEC should be informed of the yearly progress of the study.

2. HEC has approved recruitment of 30 patients on this study.

3. PI and other investigators should co-operate fully with data and safety monitoring sub-committee(DSMSC), who will monitor the trial from time to time.

4. The decision was arrived at through consensus. Neither PI nor any of proposed study teammembers was present during the decision making of the HEC,

5. At the time of PI's retirement/intention to leave the institute, study responsibility should betransferred to colleague after obtaining clearance from HOD, Status report, including accountsdetails should be submitted to HOD, DSMSC and extramural sponsors.

6. The HEC functions in accordance with the ICH-GCP/ICMR/Schedule Y guidelines.

7. In case of any new information or any SAE, which could affect any study, must be informed toHEC, DSMSC and sponsors. The PI should report SAEs occurred for HEC approved studies within7 days of the occurrence of the SAE. If the SAE is 'Death', the IRB Secretariat will receive the SAEreporting form within 24 hours.ot the cccurence.

a. The exact alteration/amendment should be specified and indicated where theamendment occurred in the original project. (Page no. Clause no. etc.)

b. Alteration in the budgetary status should be clearly indicated and the revised budget formshould be submitted

c. If the amendments require a change in the consent form, the copy of revised ConsentForm should be submitted to Ethics Committee for approval.

Final approval Project No. 856Page 2 of 3

8. In the events of any protocol amendments, HEC must be informed and the amendments should behighlighted in clear terms as follows:

-d. If the amendment demands a re-Iook at the toxicity or side effects to patients, the same

should be documented.e. If there are any amendments in the trial design, these must be incorporated in the

protocol, and other study documents. These revised documents should be submitted forapproval of the SRC and HEC, only then can they be implemented.

f. Approval for amendment changes must be obtained prior to implementation of changes.Without including all the above points, the amendment is unlikely to be approved by theEthics committee.

g. Any deviation/violation/waiver in the protocol must be informed to the HEC.

Thanking You,

Yours Sincerely,

~ . JV Divatlal_ Member Secretary,

Human Ethics Committee-I

Final approval Project No. 856Page 3 of 3

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